Registration Activities Clause Samples
The 'Registration Activities' clause outlines the requirements and procedures for parties to register or enroll in a particular program, service, or event as stipulated in the agreement. Typically, this clause details the steps necessary for successful registration, such as submitting required documentation, meeting eligibility criteria, and adhering to specified deadlines. Its core practical function is to ensure that all participants are properly identified and authorized, thereby facilitating orderly administration and compliance with the agreement's terms.
Registration Activities. In conducting registration activities, Cypress shall use commercially reasonable efforts to obtain in a timely manner NDA approvals and subsequently all additional necessary price and reimbursement approvals by the health/regulatory authorities of the Licensed Territory; provided, however that the parties acknowledge that such price and reimbursement approvals may not be granted. Cypress shall also keep ▇▇▇▇▇▇ ▇▇▇▇▇ fully informed of the registration process through the Steering Committee and upon request of ▇▇▇▇▇▇ ▇▇▇▇▇, shall allow ▇▇▇▇▇▇ ▇▇▇▇▇ representatives to participate in substantive meetings with the health/regulatory authorities of the Licensed Territory, if permitted by such health/regulatory authorities.
Registration Activities. Regulatory strategy for the Product and all decision-making with respect thereto shall be determined by the JDC. Prior to the Effective Date, Replidyne has prepared and submitted to the FDA a NDA for a Tablet in a 300 mg dosage. Replidyne and Forest will collaborate to develop and prepare for submission any supplemental NDAs or additional NDAs for the Products, with the specific responsibilities of each party’s personnel to be assigned by the JDC based on the availability of expertise and resources within each party’s organization. Replidyne shall hold the NDA for the Tablet and any subsequent supplemental NDAs for the Tablet until approval of the NDA for the Tablet, at which time Forest will become the holder of such NDA. The IND and NDA for the Oral Suspension will be filed in Replidyne’s name, and Replidyne shall hold the NDA and any subsequent supplemental NDAs for the Oral Suspension until approval of the NDA for the Oral Suspension, at which time Forest will become the holder of such NDA. Irrespective of which party prepares any such NDA or portion thereof, the other party shall be given the opportunity to review and provide comments on any such submission and no such NDA (including any supplemental NDA) shall be submitted for filing to the FDA without the mutual agreement of Forest and Replidyne, such consent not to
Registration Activities. In conducting registration activities, Cypress shall use Commercially Reasonable Efforts to obtain in a timely manner NDA approvals and any additional Regulatory Approvals with respect to Licensed Product by the health/regulatory authorities of the United States, and if determined appropriate by Cypress or Forest after review by the Steering Committee as contemplated in Section 9.2, Canada; provided, however, that the parties acknowledge that such Regulatory Approvals may not be granted. Cypress shall also keep ▇▇▇▇▇▇ ▇▇▇▇▇ fully informed of the registration process through the Steering Committee and upon request of ▇▇▇▇▇▇ ▇▇▇▇▇, shall allow ▇▇▇▇▇▇ ▇▇▇▇▇ representatives to participate in substantive meetings with the health/regulatory authorities of the Licensed Territory, if permitted by such health/regulatory authorities.
Registration Activities. Forest shall use commercially reasonable efforts to obtain or assist Cypress in obtaining in a timely manner NDA approvals and any additional Regulatory Approvals with respect to Licensed Product by the health/regulatory authorities of the United States, and if determined appropriate by Cypress or Forest after review by the Steering Committee as contemplated in Section 9.2 of the License Agreement, Canada. Upon the Effective Date, Cypress shall appoint Forest as agent for Cypress for purposes of the IND and with respect to the NDA for Licensed Product; provided that, a representative of Cypress (the "Cypress FDA Contact") shall be the primary contact with the FDA prior to commencement of the second Phase III clinical trial for Licensed Product or such other time as mutually agreed. Forest shall be primarily responsible for NDA preparation and submission, and Cypress shall hold the NDA for Licensed Product. Cypress shall review and provide comments on the NDA for Licensed Product, and Forest agrees that it shall not submit any NDA to the FDA until Cypress and Forest mutually agree to such NDA. Forest and Cypress shall keep one another fully informed of the registration process of Licensed Product through the Joint Development Committee.
Registration Activities. In conducting registration activities, Cypress shall use commercially reasonable efforts to obtain in a timely manner NDA approvals and subsequently all additional necessary price and reimbursement approvals by the health/regulatory authorities of the Licensed Territory; provided, however that the parties acknowledge that such price and reimbursement approvals may not be granted. Cypress shall also keep Pierre Fabre fully informed of the registration process through the ▇▇▇▇▇▇▇▇ ▇▇▇mittee and upon request of Pierre Fabre, shall allow Pierre Fabre representatives to participat▇ ▇▇ ▇▇▇▇▇▇▇tive meetings ▇▇▇▇ ▇▇▇ *Confidential Treatment Requested
Registration Activities. Report in this section the number of applicants whom applied for registration, registration renewal, or registration amendment, and the actual number of registrations, registration renewal, or registration amendment were approved. All time spent by the county personnel to provide registration, registration renewal, and registration amendment will be indicated in the last column. Registration actviities will include reviewing the application for the registration of industrial hemp cultivation, collecting registration fees, entering application information, verifying application information, and issuing registration number.
Registration Activities